Retrieval Tools System (2019-04-01)
- Starting date:
- April 1, 2019
- Posting date:
- February 14, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-72311
Last updated: 2020-02-14
Affected Products
- Retrieval Tools
- Implant Retrieval Instrument External Hex and Tri-Channel NP/RP 22 mm
- Implant Retrieval Instrument External Hex and Tri-Channel NP/RP 31 mm
- Implant Retrieval Instrument Conical Connection NP and External Hex WP 22 mm
- Implant Retrieval Instrument Conical Connection RP and Tri-Channel WP 22 mm
Reason
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in scope of this recall remain sterile during their shelf-life.
Affected products
A. Retrieval Tools
Lot or serial number
73430
73562
73585
Model or catalog number
37503
37504
Companies
- Manufacturer
-
Nobel Biocare AB
Vastra Hamngatan 1
GOTEBORG
40226
SWEDEN
B. Implant Retrieval Instrument External Hex and Tri-Channel NP/RP 22 mm
Lot or serial number
73296
73315
73421
73491
73595
73600
Model or catalog number
37471
Companies
- Manufacturer
-
Nobel Biocare AB
Vastra Hamngatan 1
GOTEBORG
40226
SWEDEN
C. Implant Retrieval Instrument External Hex and Tri-Channel NP/RP 31 mm
Lot or serial number
37472
Model or catalog number
37472
Companies
- Manufacturer
-
Nobel Biocare AB
Vastra Hamngatan 1
GOTEBORG
40226
SWEDEN
D. Implant Retrieval Instrument Conical Connection NP and External Hex WP 22 mm
Lot or serial number
73165
73256
73614
Model or catalog number
37474
Companies
- Manufacturer
-
Nobel Biocare AB
Vastra Hamngatan 1
GOTEBORG
40226
SWEDEN
E. Implant Retrieval Instrument Conical Connection RP and Tri-Channel WP 22 mm
Lot or serial number
73182
73298
73601
Model or catalog number
37475
Companies
- Manufacturer
-
Nobel Biocare AB
Vastra Hamngatan 1
GOTEBORG
40226
SWEDEN